Back to resultsEfficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
Primary Purpose
Prostatic Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cetuximab
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Adenocarcinoma of the Prostate, Prostate cancer, Pre-Prostatectomy, Neoadjuvant
Eligibility Criteria
Inclusion Criteria:
- Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3.
- Recent (< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis.
- Appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (Zubrod scale).
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x ULN.
- Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
- Patients must have no history of congestive heart failure or previous MI within the last 12 months.
Exclusion Criteria:
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
- Unable to tolerate transrectal ultrasound.
- Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
- Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
- Patients on oral steroid medications are not eligible.
- Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
- Prior severe infusion reaction to a monoclonal antibody.
Sites / Locations
- Baylor College of Medicine - Methodist Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Data not available PI relocated
Arm Description
No verifiable data available, PI relocated
Outcomes
Primary Outcome Measures
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
No verifiable data available, PI relocated
Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
No verifiable data available, PI relocated
Secondary Outcome Measures
PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
No verifiable data available, PI relocated
Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
No verifiable data available, PI relocated
Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
No verifiable data available, PI relocated
Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
No verifiable data available, PI relocated
Full Information
NCT ID
NCT00448097
First Posted
March 14, 2007
Last Updated
March 15, 2016
Sponsor
The Methodist Hospital Research Institute
Collaborators
Bristol-Myers Squibb, Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00448097
Brief Title
Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
Official Title
A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of patient population - slow accrual
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Methodist Hospital Research Institute
Collaborators
Bristol-Myers Squibb, Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal of the prostate.
Detailed Description
With the larger number of men who undergo screening with assays for serum prostate specific antigen, urologists continue to see considerable numbers of patients with locally advanced prostate disease. There is a higher risk of treatment failure in any patient with a tumor that extends through the prostate capsule, more aggressive pathology (Gleason score of 7 or higher), or patients with a PSA of greater than 10 ng/ml. The rationale for adding molecular targeted drugs such as Cetuximab (epithelial growth factor inhibitor), with or without chemotherapy such as Docetaxel, is that such therapy has the potential to demonstrate tumor shrinkage of the prostate and, in addition, micrometastatic cells. Cetuximab alone or Cetuximab plus Docetaxel utilizing the preprostatectomy model, with the adjuvant delivery of Cetuximab for 6 months, will provide data for the following points:
demonstration of a PSA response prior to prostatectomy;
demonstration whether a change in the natural history, with a delay in the onset of metastatic disease in patients with advanced local prostate cancer, can be achieved;
laboratory and tissue correlation to assess changes in proliferative, apoptosis, and pathologic parameters; and
metabolic imaging utilizing CT-PET with FDG to assess whether this will be a useful modality in exhibiting a response to therapy, compared with conventional radiographic imaging.
This will provide the basis for future development of neoadjuvant chemotherapy prior to prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Adenocarcinoma of the Prostate, Prostate cancer, Pre-Prostatectomy, Neoadjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Data not available PI relocated
Arm Type
Other
Arm Description
No verifiable data available, PI relocated
Intervention Type
Drug
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
No verifiable data available, PI relocated
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
No verifiable data available, PI relocated
Primary Outcome Measure Information:
Title
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
Description
No verifiable data available, PI relocated
Time Frame
during study
Title
Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
Description
No verifiable data available, PI relocated
Time Frame
during study
Secondary Outcome Measure Information:
Title
PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
Description
No verifiable data available, PI relocated
Time Frame
during study
Title
Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
Description
No verifiable data available, PI relocated
Time Frame
during study
Title
Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
Description
No verifiable data available, PI relocated
Time Frame
during study
Title
Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
Description
No verifiable data available, PI relocated
Time Frame
during study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3.
Recent (< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis.
Appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (Zubrod scale).
Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x ULN.
Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
Patients must have no history of congestive heart failure or previous MI within the last 12 months.
Exclusion Criteria:
Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
Unable to tolerate transrectal ultrasound.
Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
Patients on oral steroid medications are not eligible.
Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
Prior severe infusion reaction to a monoclonal antibody.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Amato, DO
Organizational Affiliation
Baylor College of Medicine - Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine - Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9041461
Citation
Prewett M, Rockwell P, Rockwell RF, Giorgio NA, Mendelsohn J, Scher HI, Goldstein NI. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J Immunother Emphasis Tumor Immunol. 1996 Nov;19(6):419-27. doi: 10.1097/00002371-199611000-00006.
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Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
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